FDA.reportPublic FDA data

Application 077896

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CICLOPIROXCICLOPIROXGEL;TOPICAL0.77%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077896-001CICLOPIROXCICLOPIROX0.77%GEL / TOPICALAB2008-06-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A077896-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077896-001CICLOPIROX0.77%GEL / TOPICALAB2008-06-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077896-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiclopiroxCICLOPIROXAcella Pharmaceuticals, LLCa08137a9-331f-4615-9752-e2cb52b3d8fc2026-07-10Warnings, Adverse reactionsName fallback
brand name: Ciclopirox
generic name: CICLOPIROX
CiclopiroxCICLOPIROXBryant Ranch Prepackd7e22682-1485-47e5-b6ae-94534bd3d8892026-06-22Warnings, Adverse reactionsName fallback
brand name: Ciclopirox
generic name: CICLOPIROX
CiclopiroxCICLOPIROXAcella Pharmaceuticals, LLC2c67dd09-ab1f-4ccf-97b5-421356f64f222026-06-19Warnings, Adverse reactionsName fallback
brand name: Ciclopirox
generic name: CICLOPIROX
CiclopiroxCICLOPIROXPreferred Pharmaceuticals, Inc.efcd78c0-2426-4fcc-a1c8-527e4e6f99d32026-03-27Warnings, Adverse reactionsName fallback
brand name: Ciclopirox
generic name: CICLOPIROX
CICLOPIROXCICLOPIROXBryant Ranch Prepackf3e0ea78-42c0-4430-b299-fffee9e09c162026-03-18Warnings, Adverse reactionsName fallback
brand name: CICLOPIROX
generic name: CICLOPIROX
CICLOPIROXCICLOPIROXEncube Ethicals, Inc.cb456f2e-6645-4cc4-8e71-299c47ccb6b72026-01-30Warnings, Adverse reactionsName fallback
brand name: CICLOPIROX
generic name: CICLOPIROX
ciclopiroxCICLOPIROXGlenmark Pharmaceuticals Inc., USA3c22416e-4293-4ba5-a983-137cbc6022db2026-01-23Warnings, Adverse reactionsName fallback
brand name: ciclopirox
generic name: CICLOPIROX
CICLOPIROXCICLOPIROXPreferred Pharmaceuticals Inc.eb7b7163-2ee7-447a-b585-7a240070f84b2026-01-19Warnings, Adverse reactionsName fallback
brand name: CICLOPIROX
generic name: CICLOPIROX
CiclopiroxCICLOPIROXA-S Medication Solutionsb281493f-ce8c-42f8-95c7-2eb1c97121572025-11-12Warnings, Adverse reactionsName fallback
brand name: Ciclopirox
generic name: CICLOPIROX
CICLOPIROXCICLOPIROXBryant Ranch Prepack1548af93-0dc1-4606-865f-6201b2bb7de12025-10-22Warnings, Adverse reactionsName fallback
brand name: CICLOPIROX
generic name: CICLOPIROX
CiclopiroxCICLOPIROXChartwell RX, LLC8ce98020-5615-4332-bf57-72777e2ce0382025-10-21Warnings, Adverse reactionsName fallback
brand name: Ciclopirox
generic name: CICLOPIROX
CICLOPIROXCICLOPIROXEncube Ethicals, Inc.79084b47-7481-4926-9837-e08f633b1ddf2025-10-13Warnings, Adverse reactionsName fallback
brand name: CICLOPIROX
generic name: CICLOPIROX
CICLOPIROXCICLOPIROXBryant Ranch Prepack51993bbb-f145-4662-8138-4db774cc05132025-09-16Warnings, Adverse reactionsName fallback
brand name: CICLOPIROX
generic name: CICLOPIROX
ciclopiroxCICLOPIROXBryant Ranch Prepack810bfb01-a69d-4b00-ac2d-b92e7ddad9f92025-08-08Warnings, Adverse reactionsName fallback
brand name: ciclopirox
generic name: CICLOPIROX
CiclopiroxCICLOPIROXSun Pharmaceutical Industries, Inc.b44b190b-8e2a-4937-a6c5-92f37911e7f82025-07-07Warnings, Adverse reactionsName fallback
brand name: Ciclopirox
generic name: CICLOPIROX
CICLOPIROXCICLOPIROXPadagis US LLCb6a02568-867b-4c7b-890f-5d28bf0b363d2024-11-01Warnings, Adverse reactionsName fallback
brand name: CICLOPIROX
generic name: CICLOPIROX
CiclopiroxCICLOPIROXBryant Ranch Prepackaaa27021-68a6-486c-9095-56de1140ca2d2024-03-21Warnings, Adverse reactionsName fallback
brand name: Ciclopirox
generic name: CICLOPIROX
CiclopiroxCICLOPIROXActavis Pharma, Inc.eef13684-751f-47e1-b75e-3401a0e6e20f2023-10-30Warnings, Adverse reactionsName fallback
brand name: Ciclopirox
generic name: CICLOPIROX
CiclopiroxCICLOPIROXBryant Ranch Prepack9c7d1fd9-71dd-4bbb-aed2-7db5cffa8b5a2023-07-17Warnings, Adverse reactionsName fallback
brand name: Ciclopirox
generic name: CICLOPIROX
CICLOPIROXCICLOPIROXBryant Ranch Prepack9861c88d-528f-4e30-8c1e-56ac3afec76c2023-07-17Warnings, Adverse reactionsName fallback
brand name: CICLOPIROX
generic name: CICLOPIROX

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0407CiclopiroxCiclopiroxE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent